Biomarkers in Patients With Previously Untreated Invasive Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
A Study of the Local and Systemic Effects of Intraperitoneal Chemotherapy in the Treatment of Previously-Untreated, Invasive Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma
5 other identifiers
observational
39
1 country
9
Brief Summary
This research trial studies biomarkers in patients with previously untreated invasive ovarian epithelial, fallopian tube, or primary peritoneal cancer. Studying samples of tumor tissue, peritoneal cavity fluid, and blood from patients receiving chemotherapy directly into the abdominal cavity (intraperitoneal) may help doctors learn more about the effects of intraperitoneal chemotherapy on cells. It may also help doctors identify and learn more about biomarkers related to cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2011
CompletedFirst Posted
Study publicly available on registry
February 14, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedMay 22, 2018
May 1, 2018
6.8 years
February 11, 2011
May 21, 2018
Conditions
Outcome Measures
Primary Outcomes (4)
Amount of peritoneal fluid obtained during each attempted extraction of peritoneal fluid or washing
Up to 1 year
Presence of immune cells measured by immunohistochemistry in archival formalin-fixed, paraffin-embedded tumor tissue
The staining intensities of immune cells detected in immunohistochemically stained paraffin tissue will be described using descriptive statistics such as the median, 1st and 3rd quartiles of staining intensities. Spearman's correlation coefficient will be used to assess associations between these intensities and the cell counts obtained from pre-treatment peripheral blood and peritoneal fluids. Boxplots or scattergrams will be used to display these data.
Up to 1 year
Quantity of each type of immune cells identified in the peritoneal fluid or washings specimens
A Wilcoxon signed rank test will be used to evaluate the null hypothesis that the expectation of the pretreatment cell counts is equal to the expectation of the post-treatment cell count. Descriptive statistics such as the mean, variance, median, 1st and 3rd quartiles as well as the spearman correlation between pre- and post- treatment cell counts will be reported for each cell type. Boxplots or scattergrams will be used to display the results. The mean, variance and quartiles of the amount of fluid recovered from pre-treatment and post-treatment samples will also be reported.
Up to 1 year
Quantity of each type of mononuclear cells in peripheral blood
The number and type of mononuclear cells in peripheral blood will be described using descriptive statistics such as the median, 1st and 3rd quartiles. Spearman's correlation coefficient will be used to assess associations between pre- and post- treatment values. Boxplots or scattergrams will be used to display these data. A Wilcoxon signed rank test, that involves the patients' pre- and post- treatment measurements, will be used to evaluate the null hypothesis that these cell counts are unchanged by treatment.
Up to 1 year
Study Arms (2)
Group A (IP catheter removed)
Archival formalin-fixed, paraffin-embedded tumor (collected during previous surgery), peritoneal fluid, peritoneal wash, and blood (for cell, plasma, and serum isolation) samples are collected before course one and blood (for cell, plasma, and serum isolations) is collected before courses two and three for translational research.
Group B (IP catheter in place)
Archival formalin-fixed, paraffin-embedded tumor (collected during previous surgery), peritoneal fluid, peritoneal wash, and blood (for cell, plasma, and serum isolation) samples are collected before course one and peritoneal fluid, peritoneal wash, and blood (for cell, plasma, and serum isolations) before courses two and three for translational research.
Interventions
Correlative studies
Eligibility Criteria
You may qualify if:
- Patients must be enrolled on GOG-0252
- Patients must have an IP catheter placed prior to initiating platinum and taxane-based chemotherapy on GOG-0252
- Patients must have signed an approved informed consent for specimen collection and participation in this translational research study
You may not qualify if:
- Patients who are not enrolled on GOG-0252
- Patients who have not had an IP catheter placed prior to initiating platinum and taxane-based IP chemotherapy on GOG-0252
- Patients who did not sign an approved informed consent for specimen collection and participation in this translational research study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (9)
Sudarshan K Sharma MD Limted-Gynecologic Oncology
Hinsdale, Illinois, 60521, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, 50010, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Edwards
NRG Oncology
Study Design
- Study Type
- observational
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2011
First Posted
February 14, 2011
Study Start
March 1, 2011
Primary Completion
January 1, 2018
Last Updated
May 22, 2018
Record last verified: 2018-05